FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Epinephrine Injection, Auto-Injector
Status: Currently in Shortage
»Date first posted: 05/09/2018
»Therapeutic Categories: Pulmonary/Allergy

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Adamis Pharmaceuticals Corporation (Reverified 12/17/2019)

Company Contact Information:
800-230-3935

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Carton containing two SYMJEPI (epinephrine injection, USP) 0.3 mg single-dose, pre-filled syringes (NDC 0781-3442-20) Available
Carton containing two SYMJEPI (epinephrine injection, USP) 0.15 mg single-dose, pre-filled syringes (NDC 0781-3448-20) Available

Impax Laboratories (Revised 06/01/2020)

Company Contact Information:
877-99-Impax(46729); option 2

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.15 mg/0.15 mL epinephrine injection, USP, pre-filled auto-injector (two pack)(NDC 0115-1695-49) On allocation to current customers.

Dear Healthcare Provider Letter


Patient Inspection Instructions
Dear Healthcare Provider Letter for Expiry Extension for Select Lots of Epinephrine 0.15 mg and 0.30 mg Auto-Injectors
Manufacturing delays
0.3 mg/0.3 mL epinephrine injection, USP, pre-filled auto-injector (two pack)(NDC 0115-1694-49) On allocation to current customers.

Important Safety Information for Healthcare Providers


Important Safety Information for Consumers
Dear Healthcare Provider Letter for Expiry Extension for Select Lots of Epinephrine 0.15 mg and 0.30 mg Auto-Injectors
Manufacturing delays

Kaleo (Reverified 03/18/2020)

Company Contact Information:
877-30-AUVIQ (1-877-302-8847)

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Carton containing two AUVI-Q (epinephrine injection, USP) 0.3 mg auto-injectors and a single AUVI-Q Trainer (NDC 60842-023-01) Available AUVI-Q is readily available and not currently in shortage.
Carton containing two AUVI-Q (epinephrine injection, USP) 0.15 mg auto-injectors and a single AUVI-Q Trainer (NDC 60842-022-01) Available AUVI-Q is readily available and not currently in shortage.
Carton containing two AUVI-Q (epinephrine injection, USP) 0.1 mg auto-injectors and a single AUVI-Q Trainer (NDC 60842-021-01) Available AUVI-Q is readily available and not currently in shortage.

Mylan Specialty (Revised 05/26/2020)

Company Contact Information:
800-RXMYLAN (1-800-796- 9526)

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.3 mg (EpiPen® NDC 49502-500-02, pack of 2; NDC 49502-500-01, individual) (Authorized Generic NDC 49502-102-02, pack of 2; NDC 49502-102-01, individual) Available Production output from Mylan’s manufacturing partner Meridian Medical Technologies, a Pfizer company, has improved in recent months. Supplies are routinely shipping and, as a result, are more consistently available at the pharmacy level. In the event patients experience difficulty accessing product, they can continue to contact Mylan Customer Relations at 800-796-9526 for assistance in locating alternative pharmacies.

Dear Healthcare Provider Letter for Extended Expiration Dates for All Lots of EpiPen 0.3 mg Auto-Injectors and its Authorized Generic


Dear Healthcare Provider Letter: Important Safety Information This letter is to communicate important safety information and is not a recall of the product.
0.15 mg (EpiPen® NDC 49502-501-02) (Authorized Generic NDC 49502-101-02) Available Production output from Mylan’s manufacturing partner Meridian Medical Technologies, a Pfizer company, has improved in recent months. Supplies are routinely shipping and, as a result, are more consistently available at the pharmacy level. In the event patients experience difficulty accessing product, they can continue to contact Mylan Customer Relations at 800-796-9526 for assistance in locating alternative pharmacies.
Dear Healthcare Provider Letter: Important Safety Information This letter is to communicate important safety information and is not a recall of the product.

Teva Pharmaceuticals (Reverified 05/19/2020)

Company Contact Information:
800-545-8800

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.15 MG Epinephrine Injection, USP auto-injector (NDC 0093-5985-27) Available but sporadic supply interruptions through June, 2020
0.3 mg/mL epinephrine injection, USP, auto-injector (NDC 0093-5986-27) Available but sporadic supply interruptions through June, 2020

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